Lifestyle Interventions for Long Term Diabetes Control

NCT00364312 | Unknown

• 1 other identifier: R18DK062942
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

Lifestyle interventions have been shown to reduce heart disease risk and improve blood sugar control in clinical trials. This project will investigate whether those lifestyle interventions can be implemented long-term, in usual practice settings, by using dietitian case managers to coordinate lifestyle change in cooperation with fitness instructors and primary care clinicians.

Conditions

Type 2 Diabetes

Keywords

behavior therapy; dietary control; exercise; diabetes mellitus; behavior modification; blood glucose; clinical trial; diabetes education; health behavior; health care service utilization; obesity; quality of life

Outcome Measures

Primary Outcomes (6)

• HbA1c

• Waist circumference

• Body mass index

• Lipids

• Health care utilization

• Quality of life

Secondary Outcomes (5)

• Diet

• Physical activity

• Diabetes knowledge

• Social support

• Self-efficacy

Interventions

diet and physical activity BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• treated for type 2 diabetes within one year prior to their entry into the trial, have a BMI at or above 30, and are 18 years of age or older

You may not qualify if:

• \) end-stage renal disease (defined as being on dialysis), 2) active foot ulcers or infections (defined as an open wound or requiring drug therapy), 3) pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer) that precludes diet and physical activity changes

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Diabetes Mellitus; Health Behavior; Patient Acceptance of Health Care; Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Treatment Adherence and Compliance; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Viktor E Bovbjerg, PhD MPH

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Jayne Q Crowther, RN MSN

  University of Virginia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2004
• Study Completion: December 1, 2009
• Last Updated: August 15, 2006

Record last verified: 2006-08

Locations

US (1)